L'influence du vaccin (Article en anglais.)

Vaccine 28 (2010) 6137–6144

Contents lists available at ScienceDirect

Vaccine

journal homepage: www.elsevier.com/locate/vaccine

A randomized clinical trial assessing immunogenicity and safety of a

double dose of virosomal-adjuvanted influenza vaccine administered to

unprimed children aged 6–35 months

Susanna Espositoa, Paola Marchisioa, Filippo Ansaldib, Sonia Bianchinia, Michela Paceic,

Elena Baggia, Daria Trabattonic, Giancarlo Icardi b, Nicola Principi a,∗

a Department of Maternal and Pediatric Sciences, Università degli Studi di Milano, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico,

Via Commenda 9, 20122 Milan, Italy

b Department of Health Sciences, University of Genoa, Genoa, Italy

c Chair of Immunology, Università degli Studi di Milano, Milan, Italy

a r t i c l e i n f o

Article history:

Received 27 April 2010

Received in revised form 5 July 2010

Accepted 13 July 2010

Available online 29 July 2010

Keywords:

Influenza

Influenza vaccine

Virosomal

Immunogenicity

Reactogenicity

Children

a b s t r a c t

This study evaluated the immunogenicity of a double dose of the seasonal virosomal-adjuvanted influenza

vaccine (Inflexal V, Crucell, The Netherlands) in 65 previously unvaccinated children aged less than 3

years: 43 received double doses (two doses of 0.50mL 4 weeks apart) and 22 standard doses (two doses

of 0.25mL4 weeks apart). Both treatments evoked a response that satisfied theEMEAcriteria for adequate

immunogenicity for all three vaccine strains, but the double dose had a significantly greater effect on all

of the studied parameters of humoral and cell-mediated immune response (p < 0.05). This result was

achieved without any increase in the incidence of local and systemic adverse events. This means that

doubling the dose of the virosomal-adjuvanted influenza vaccine (i.e. administering the same dose as

that usually given to older children) effectively and safely increases the immune response to inactivated

influenza vaccine in unprimed children aged less than 3 years.

© 2010 Elsevier Ltd. All rights reserved.

1. Introduction

Because seasonal influenza can be dangerous for children

with an underlying chronic severe disease, health authorities

throughout the world have strongly recommended that they be

administered influenza vaccination [1–3]. A number of recent studies

have

...